Drug Topics June 14, 2024
Check out important updates from the FDA for the week of June 10.
FDA Approves 2 New OTC Continuous Glucose Monitors
The FDA provided clearance to 2 over-the-counter (OTC) continuous glucose monitor (CGM) systems from Abbott. The new OTC devices are based on the company’s FreeStyle Libre sensing technology, which is the most widely used CGM system in the world. The approvals come shortly after Dexcom received the first CGM OTC approval for its Stelo Glucose Biosensor System.
The Libre Rio is the first OTC CGM that has a measurement range of 40-400 mg/dL, which allows the device to detect extremely low or high glucose events. The CGM provides measurements via a biosensor that is placed on the back of...
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